Pragmatic applications of implementation science frameworks to regulatory science: an assessment of FDA Risk Evaluation and Mitigation Strategies (REMS) (2014–2018)

Background A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program for certain medications with serious safety concerns required by the U.S. Food and Drug Administration (FDA) of manufacturers to implement to help ensure the benefits of the medication outweigh its risks. FDA is encouraging “the research community to develop novel methods for assessing REMS,” conveying the unmet need for a standardized evaluation method of these regulatory-mandated healthcare programs. The objective of this research is to evaluate FDA REMS assessment plans using established implementation science frameworks and identify opportunities for strengthening REMS evaluation. Methods A content analysis was conducted of publicly available assessment plans for all REMS programs (N = 23) approved 1/1/2014–12/31/2018 for new drug applications (NDAs) and biologics license applications (BLAs) requiring FDA-mandated Elements to Assure Safe Use (ETASU). Blinded reviewers critically appraised REMS assessment measures (n = 674) using three established implementation science frameworks: RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance); PRECEDE-PROCEED (Predisposing, Reinforcing, and Enabling Constructs in Educational/Environmental Diagnosis and Evaluation – Policy, Regulatory, and Organizational Constructs in Educational and Environmental Development); and CFIR (Consolidated Framework for Implementation Research). Framework constructs were mapped to REMS Assessment categories as defined by FDA Guidance for Industry to evaluate congruence. Results REMS assessment measures demonstrated strong congruence (> 90% mapping rate) with the evaluative constructs of RE-AIM, PRECEDE-PROCEED, and CFIR. Application of the frameworks revealed that REMS assessment measures heavily emphasize implementation and operations, focus less on health outcomes, and do not evaluate program context and design assumptions. Conclusions Implementation science frameworks have utility for evaluating FDA-mandated drug safety programs including the selection of primary measures to determine whether REMS goals are being met and of secondary measures to evaluate contextual factors affecting REMS effectiveness in varying organizational settings.

Risk Management in Moroccan Healthcare Organizations: An Overview

The institute of medicine asserts that to err is human: building a safer health system (Linda T et al, 2000). For this reason risk management takes an important place in healthcare decision-making process within the objective of ensuring the management of emergencies, which cannot always be anticipated in advance, but will cause serious consequences if they occur (Li Guo, 2015). In fact, risk management is defined as a set of activities and processes of identification, analysis, evaluation, treatment, reducing, communication and monitoring potential failures and adverse events in purpose to provide a better quality of service and a system able to insure protection of patients, workers, equipment, stakeholders and the environment. Thus, this paper aims to present a structured review of publications that highlight risk management topic in healthcare sector by proposing new approaches, applying existed techniques or implementing risk assessment plans in Moroccan healthcare organizations especially Moroccan hospitals.

How School Leader Implement the Curriculum? Problems, Prospects, and Way Forward

The principal has a multidimensional role, which includes academic management, providing a suitable environment for learning, maintaining proper institutional discipline and the implementation of the curriculum in their academic institutions. The aim of the study was to explore the role of principals in the implementation of the curriculum in the school. The nature of the study was descriptive in nature, having 77 secondary school principals constitutes the population of the study, of which 70 principals were taken as a sample of the study using standardized sample size determination techniques. The data was collected through a validated closed-ended questionnaire with a 5-point Likert scale. The collected data were analyzed using chi-square statistics. The results reveal that the opportunities were provided to staff members for the development of skills and attitudes to support curriculum implementation, the curriculum materials were used to diagnose the potential barriers in the process of curriculum implementation, and the principal provides facilities for the development of standard assessment plans to implement the curriculum.

Innovating Pathology Learning via Kahoot! Game-based Tool: A Quantitative Study of Students’ Perceptions and Academic Performance

IntroductionPathology teaching for medical undergraduate students linking basic and clinical sciences together is a challenging task. Kahoot! is a game-based online digital formative assessment tool that can engage students in its learning. This study analyzed the effect of Kahoot! use on studentś learning of Pathology.MethodsThe study was carried out on the first-year Pathology students at Helwan University, Faculty of Medicine, after ending a basic Pathology course. The study is a retrospective quasi-experimental quantitative study. Academic performance of students in Pathology was compared between Kahoot! and non-Kahoot! users (55 students each). In addition, an online survey was introduced to the 55 Kahoot! user students to investigate their perceptions on Kahoot!. Survey and test score data were analyzed by appropriate tests using IBM-SPSS (Statistical Package for Social Sciences) Version 21.0. The level of significance was P <0.05.ResultsKahoot! enhanced Pathology understanding (83.6%), retaining knowledge (87.3%), made learning fun and motivating (89.1%). Other mentioned advantages of Kahoot! were practicing for the exam (40%), simple and easy to use (36.4%), competitive (18.2%), self-confidence booster (10.9%), forming a comprehensive image of the lecture (9%), quick (9%), and imagining skills booster (5.5%). Mentioned disadvantages included no explanation for the answers to the questions (20%). A quarter of the students stated that the time limit for the questions was short (27.3%). Kahoot! use was significantly associated with better Pathology academic performance (P=0.001), and it was not related to the general academic performance of the students (P=0.06). The majority of users (85.4%) recommended its continuous future use.ConclusionsThe study offers an endorsement to the use of Kahoot! for gamifying formative assessment of Pathology and can provide a basis for the design of an online Kahoot!-based continuous formative assessment plans implemented outside-classroom in the Pathology curricula.

Person-Centered Health Care: An Approach That Integrates Acute and Long-Term Care

The concept of person-centered health care (PCHC) shifts from the individual’s diagnosis to the holistic health and individual social needs. PCHC is defined by WHO as “empowering people to take charge of their own health rather than being passive recipients of services.” This care strategy is based on the belief that if an individual is an equal partner in care planning and care decision making process, and that his/her view, input, and experiences can help improve overall health outcomes. PCHC requires a reconfiguration of the health care system. A vertical or/and horizontal integration of a variety of healthcare settings is necessary. A proposed 5-year PCHC pilot study in Taiwan’s Changhua county aims to reduce unnecessary hospitalizations by 15% in 4 years. Year one will focus on alignment of health care providers, baseline data collection, and assessment plans development. PCHC intervention will start in years two to five. Part of a symposium sponsored by International Comparisons of Healthy Aging Interest Group.

An Indirect Evaluation of Program Educational Objectives and Student Outcomes for Engineering Programs: A Case Study

Outcome and objective assessment is a method for determining whether students and graduates have learned, have retained, and can apply what they have been taught. Assessment plans have to include a statement of educational objectives, measurements of attainment of the objectives, and use of the assessment results for continuous improvement. In this paper, the experience of the Electrical Engineering program at Al-Imam Mohammad Ibn Saud Islamic University is used as an example of how an indirect assessment method is established and implemented. Many surveys have been used and contributed to the numerical analysis for the indirect assessment of the program outcomes and achievements. The indirect assessment results indicate that the target levels are achieved for all the seven program outcomes and the three objectives that have been considered.

Ocean sentinel albatrosses locate illegal vessels and provide the first estimate of the extent of nondeclared fishing

With threats to nature becoming increasingly prominent, in order for biodiversity levels to persist, there is a critical need to improve implementation of conservation measures. In the oceans, the surveillance of fisheries is complex and inadequate, such that quantifying and locating nondeclared and illegal fisheries is persistently problematic. Given that these activities dramatically impact oceanic ecosystems, through overexploitation of fish stocks and bycatch of threatened species, innovative ways to monitor the oceans are urgently required. Here, we describe a concept of “Ocean Sentinel” using animals equipped with state-of-the-art loggers which monitor fisheries in remote areas. Albatrosses fitted with loggers detecting and locating the presence of vessels and transmitting the information immediately to authorities allowed an estimation of the proportion of nondeclared fishing vessels operating in national and international waters of the Southern Ocean. We found that in international waters, more than one-third of vessels had no Automatic Identification System operating; in national Exclusive Economic Zones (EEZs), this proportion was lower on average, but variable according to EEZ. Ocean Sentinel was also able to provide unpreceded information on the attraction of seabirds to vessels, giving access to crucial information for risk-assessment plans of threatened species. Attraction differed between species, age, and vessel activity. Fishing vessels attracted more birds than other vessels, and juveniles both encountered fewer vessels and showed a lower attraction to vessels than adults. This study shows that the development of technologies offers the potential of implementing conservation policies by using wide-ranging seabirds to patrol oceans.

Pedagogical Content Knowledge (PCK) pada Mahasiswa Calon Guru Matematika

Pedagogical Content Knowledge (PCK) is one of the basic knowledge that pre -services teachers must-have. PCK explained how the teacher linked material knowledge with knowledge about teaching. By mastering PCK pre-services teachers are expected to carry out effective learning. The purpose of this study is to describe the ability of pre-service mathematics teacher PCK. This type of research is descriptive qualitative. The subjects of this study were two pre-service teachers for the Mathematics Education Department at the Universitas Sarjanawiyata Tamansiswa. The instruments used were observation sheets, questionnaire sheets, linear program test questions, and interview guidelines. The data analysis technique of this study used descriptive qualitative analysis techniques. The results showed that based on indicators of PCK ability, pre-service teachers already knew and understood core competencies, basic competencies, and learning indicators and could make learning objectives, learning materials, reference sources, approaches, strategies, methods, and mathematical learning models. In addition, pre-service teachers can also make assessment plans, both the affective, cognitive, and psychomotor domains as well as the remedial and enrichment programs. Pre-service teachers are quite flexible and confident in teaching even though there are pre-service teachers who speak in small voices and the intonation has not varied. When viewed from the material side, the material provided by pre-service teachers to students is good even though there are still a few shortcomings. In general, pre-service teachers have a good understanding of content and pedagogical knowledge in theory, but implementation in planning and learning in class is still lacking